The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Integra Interspinous Process System.
| Device ID | K121924 |
| 510k Number | K121924 |
| Device Name: | INTEGRA INTERSPINOUS PROCESS SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | SEASPINE, INC. 2302 La Mirada Dr Vista, CA 92081 |
| Contact | Nick M Cordaro |
| Correspondent | Nick M Cordaro SEASPINE, INC. 2302 La Mirada Dr Vista, CA 92081 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2013-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981129705 | K121924 | 000 |
| 10889981076191 | K121924 | 000 |
| 10889981076207 | K121924 | 000 |
| 10889981076214 | K121924 | 000 |
| 10889981076221 | K121924 | 000 |
| 10889981076238 | K121924 | 000 |
| 10889981096199 | K121924 | 000 |
| 10889981096236 | K121924 | 000 |
| 10889981096243 | K121924 | 000 |
| 10889981096250 | K121924 | 000 |
| 10889981096267 | K121924 | 000 |
| 10889981096274 | K121924 | 000 |
| 10889981096281 | K121924 | 000 |
| 10889981120603 | K121924 | 000 |
| 10889981076184 | K121924 | 000 |